Microbiologics Inc recalls LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of…

Recall date

March 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0637-2022

FDA classification

Class III

Brand / firm

Microbiologics Inc

Sold / distributed

International distribution in the countries of Canada and Germany.

Why it was recalled

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.